Seafood Facility - Pranas S.A.


September 19, 2012


Mr. Sebastian Greco, President
Pranas S.A.
Pescadores 1156
B7603GGD- Mar del Plata
Buenos Aires, Argentina

Reference No. # 348379

Dear Mr. Greco:

Your firm recently provided a copy of your HACCP plan (dated January 2012) for “Anchovies In Salt Brine” to the U.S. Food and Drug Administration, along with additional information related to your processing procedures.  The information was submitted to FDA as part of your request for removal from Import Alert #16-74.  Although we granted removal from Import Alert #16-74 because the information demonstrated that the market form of your product was not covered in the alert, review of the documentation revealed serious violations of the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123).  This letter describes FDA’s concerns and provides contact information for a response. 

In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4).  Accordingly, your anchovies in salt brine are adulterated, in that they have been prepared, packed, or held under conditions whereby they may have been rendered injurious to health. 

You may find the Act, the seafood HACCP regulation and the 4th Edition of the Fish and Fisheries Products Hazards and Controls Guidance (the Hazards Guide) through links in FDA's home page at The 4th Edition of the Hazards Guide can be found on our web site at:

Your significant deviations are as follows:

  1. You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (c)(1).  A food safety hazard is defined in 21 CFR 123.3(f) as "any biological, chemical, or physical property that may cause a food to be unsafe for human consumption." However, your firm’s HACCP plan for anchovies in salt brine does not identify the food safety hazard of pathogen growth and toxin formation, specifically Staphylococcus aureus and undeclared allergenic substances.

    1. Staphylococcus aureus is a pathogen likely introduced during the salting process because this process is conducted for an extended time period (i.e., listed as 12 to 24 hours) and Staphylococcus is a salt tolerant organism; therefore, FDA recommends that temperatures be controlled at or below 40° F to prevent toxin formation for the duration of the salting process.  Alternatively, your firm may choose to monitor time to ensure that the product exposure to temperatures above 40 °F is consistently less than 3 hours.

    2. With regard to the hazard of undeclared allergens, FDA recommends that your firm include a critical control point to monitor each batch of labels to ensure that labels declare the allergenic substances.  For example, your firm should monitor each batch of labels to ensure that the appropriate fish species is declared in the ingredient statement or that there is a statement “contains fish” on all the labels.

  2. You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the critical control points, to comply with 21 CFR 123.6(a) and (c)(2). A critical control point is defined in 21 CFR Part 123.3(b) as a "point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels."However, your firm's HACCP plan for anchovies in salt brine does not list critical control points necessary for controlling the reasonably likely hazards of Clostridium botulinum growth and toxin formation, and histamine formation. Specifically, your firm needs to assess the following during your hazard analysis:

    1. A critical control point for receipt of the anchovies at the dock, when being off-loaded from the harvest vessels. Your firm appears to be a primary processor receiving the fish directly from the harvest vessel, but also receives fish transported by trucks to your processing facility. As the primary processor receiving the fish directly from the harvest vessels, your firm needs to ensure that the fish were properly handled onboard the boats. This should include not only your listed strategies for histamine testing and sensory evaluation, but also a third strategy for monitoring temperatures of the fish at the time they are off-loaded at the dock.  FDA recommends temperatures of 40°F (4.4°C) or below at off-loading from the harvest vessels to demonstrate adequate chilling onboard the vessels.

      For receipt of the fish in transit from the wharf to your facility, your firm should include additional control at receipt to ensure that the fish were held at proper temperatures or with adequate ice surrounding the products during the transit period to your facility to control histamine formation.

    2. A critical control for heading, gutting, and filleting of the anchovies following  receipt, prior to the brining operation to prevent pre-formed Clostridium botulinum toxin from developing (i.e., before the fresh fish have reached an adequate salt concentration during the salting step) because of the extended time period for the salting process.

    3. A critical control point for salting.  Your plan lists b(4) as critical control points in your plan.  However your plan does not list a salting critical control point to ensure that a b(4)  is achieved as either an adequate water activity (Aw) or water phase salt (WPS) level.  Because your products undergo a b(4)  that appears to be conducted under ambient temperatures b(4)  your products should achieve a safe b(4).  Since the product undergoes a subsequent ripening process, the product must reach a “shelf stable” b(4)  to prevent the germination of Clostridium botulinum spores. 

  3. You must have a HACCP plan that, at a minimum, lists the critical limits that must be met, to comply with 21 CFR 123.6(c)(3).  A critical limit is defined in 21 CFR 123.3(c) as "the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard." However, the presalting critical control point of your HACCP plan for anchovies in salt brine listed a salting time of b(4)  that is inadequate to control the food safety hazard of histamine formation, in the absence of a critical limit for temperature. FDA recommends the following options:

    1. For the presalting step without any temperature controls, to ensure that the fish are continuously held at temperature of 40° F (4.4 °C) or below, your firm should assure that fish achieve a Aw of <0.85 within 3 hours.


    2. For the presalting step conducted for extended time periods such as the listed 12 to 20 hours, your firm should establish a temperature critical limit of 4.4°C and conduct the process under refrigerated conditions either throughout the process or until the product achieves a safe Aw.

  4. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequencies for each critical control point, to comply with 21 CFR 123.6(c)(4).  However, your firm’s revised HACCP plan for your anchovies in salt brine, does not list adequate monitoring procedures and frequencies at the following critical control points to control histamine formation.

    1. At the b(4) critical control point, your plan indicates that you will test histamine content in b(4)  flesh to control histamine. This is not an adequate control at this step because it does not ensure that the entire batch of fish was properly controlled to prevent histamine formation for the duration of the ripening step. Your firm should implement controls that prevent the formation of histamine. FDA recommends the following options as methods to control histamine formation:

      • Attain Aw or WPS (i.e. Aw < 0.85, WPS > 20%) during the presalting step sufficient to control histamine formation in order to eliminate the need for histamine control at the ripening step


      • Attain a safe Aw or WPS (i.e. Aw < 0.85, WPS > 20%) within 3 hours (including unrefrigerated handling steps prior to ripening). This will be difficult to achieve since the presalting step is not refrigerated nor are there other processing steps which could reduce the time significantly.


      • Ripen/mature the anchovies under refrigeration below 4.4°C until an Aw of 0.85 or WPS of 20% is achieved or throughout the entire process.  Your firm would need to conduct a study to determine the minimum time that the product would need to be under refrigeration.

    2. At the “Receiving” critical control point, your plan does not identify an adequate sampling frequency for testing histamine.  The monitoring frequency lists that your firm will sample uniced or inadequately iced products and also test fish samples where the internal temperatures b(4)  This does not assure that representative samples will be collected throughout the lot b(4)  if all of the products come in iced and with internal temperatures b(4). FDA recommends collecting a minimum of 18 samples routinely throughout the lot or shipment including those products that appear to have been adequately chilled.

      Further, the collection of representative samples for testing decomposition and internal temperature is unclear. The asterisk footnote under the Receiving critical control point implies that b(4)  are collected from each truck for decomposition. This is inadequate. Although those samples may include b(4), they should be more representative of the sub-lot or lot. A lot depends on how the fish are loaded on the trucks. If the fish are in large vessels or smaller totes, the samples should be collected throughout the shipment, not just from b(4). Since the fish are small, a sample should be determined by quantity, not by the number of fish. FDA recommends collecting samples of approximately 1-2 lbs.

  5. Predetermined corrective action plans included in a firm’s HACCP plan, to be taken whenever there is a deviation from a critical limit, must be appropriate to comply with 21 CFR 123.7(b).  However, your corrective action plans for your anchovies with salt brine are not appropriate at the following critical control points to control histamine and Clostridium botulinum growth and toxin formation:

    1. At the “Receiving” critical control point for histamine testing, your plan lists rejection of the lot but does not identify how your firm will correct the cause of the critical limit deviation. Your firm should address both in your corrective action plan.

    2. At the “Presalting” critical control point, your firm’s plan does not identify the disposition of potentially adulterated products and does not identify how your firm will correct the cause of the critical limit deviation.

Please respond in writing within 30 working days from your receipt of this letter.  Your response should outline the specific things you are doing to correct these violations.  Your response should include documentation, such as: a copy of any revised HACCP plan or plans; at least five (5) product days worth of monitoring records (i.e., complete production days) to demonstrate that you have implemented the revised plan or plans; any verification records; and any other useful information that would assist us in evaluating your corrections.  Providing the information in English will assist in our review.

This letter may not list all the deviations at your facility.  You are responsible for ensuring that your processing plant operates in compliance with the Act and applicable regulations, including the Seafood HACCP regulation, and the Good Manufacturing Practice regulation (21 CFR 110).  You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.

Please send your reply to Food and Drug Administration, Attention:  Maria Corpuz, Consumer Safety Officer, Office of Compliance, Division of Enforcement, Food Adulteration Assessment Branch (HFS-607), 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A.  If you have any questions regarding this letter, you may contact Ms. Corpuz via email at 



Jennifer A. Thomas
Division of Enforcement
Office of Compliance
Center for Food Safety
and Applied Nutrition

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